--- title: The 10 key changes in the GAMP 5 Second Edition canonical: "https://www.qualio.com/blog/the-10-key-changes-in-gamp-5-second-edition" pubDate: "2022-09-13T11:12:45.000Z" updatedDate: "2026-10-27T12:48:02.000Z" author: Alex Pavlović description: The unveiling of the GAMP 5 Second Edition is part of the shift to a new world order of computer system adoption. Dive into the ten key changes here. categories: [Computerized System Assurance] --- The GAMP 5 Second Edition, the newest version of the ISPE's computerized system guidance, was released in July 2022, replacing the First Edition unveiled in 2008. The [GAMP 5 Second Edition](https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition) should be seen as part of a broader industry trend taking place: the evolution from computerized system validation (CSV) to computerized system assurance (CSA). In keeping with the broad emphasis shift to agile, risk-based adoption of modern digital tools for [GxP](/blog/gxp)-regulated businesses, the Second Edition has brought 10 key changes to how 'good automated manufacturing practice' is defined. We sat down with GAMP editor Sion Wyn to take a look. ## What's new in the GAMP 5 Second Edition? ### 1. Non-linear recognition The First Edition of GAMP 5 assumed a broadly linear approach to software development, which no longer reflects how modern software is brought to life. The Second Edition recognises the largely non-linear, agile and more cyclical nature of modern software development. Iterative, incremental and exploratory models are therefore emphasized over older, linear models like the waterfall. Credit:[ hackr.io](https://hackr.io/blog/agile-vs-waterfall) ### 2. Document change The recognition of non-linear software development has a natural knock-on effect. Legacy GAMP validation documents which assume a linear software approach, like installation, operation and performance qualification documents, are no longer relevant for the Second Edition. There's therefore a shift in emphasis from traditional documents like IQs, OQs and PQs to risk-based records of information, held in appropriate systems, that take into account the modern software lifecycle. ### 3. Critical thinking Critical thinking is a huge cornerstone of computerized system assurance, both in the GAMP 5 Second Edition and the FDA's [new guidelines](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software) unveiled in September 2022. Rather than one-size-fits-all, document-heavy approaches to validation, the GAMP 5 Second Edition encourages appropriate, efficient and risk-based assurance dependent on the risk profile of the software you're implementing. The document crystallizes around the concept of critical thinking in a way the First Edition doesn't, including guidance of key areas of computerized system adoption where critical thinking should be applied, and a fresh appendix on the topic. ### 4. Update of development appendices The areas of GAMP 5 focusing on user requirements specifications (URS) and functional/design specifications have been tweaked to reflect the new world of modern, agile software. ### 5. Appendix on electronic production of records updated The rise of [cloud-based technology](/customers) and blockchain has been taken into account. The appendix also clarifies new expectations around electronic records, signatures and audit trails. ### 6. ITIL Multiple appendices have been updated to reflect the modern [ITIL](https://www.cio.com/article/272361/infrastructure-it-infrastructure-library-itil-definition-and-solutions.html) approach to software development, and to clarify links between key areas like change and incident management. ### 7. New appendix about blockchain and distributed ledger technology Alongside the tweaks to the electronic production of records section, the Second Edition of GAMP 5 also contains an entirely new appendix taking blockchain and ledger technology into account. ### 8. New appendix about AI and machine learning The GAMP 5 Second Edition acknowledges the increasingly significant role played by artificial intelligence (AI) and machine learning, and adds a new appendix to deal with the topic. ### 9. New appendix about use of agile within a GxP environment Agility is a core ingredient of the Second Edition. Alongside the recognition of agile software development, GAMP 5 encourages an agile, critical thinking- and risk-based approach to assurance of digital tools. A new section has been added to clarify these new expectations. ### 10. New appendix about modern infrastructure and infrastructure management The replacement of paper with automation and AI is a seminal, defining change for how life science companies manage quality and compliance. The Second Edition contains a fresh appendix outlining the modern GxP infrastructure, and how new digital tools should be implemented and applied. ## Watch the [video](https://www.graphicdesigneire.ie/whiteboard-explainer-video) Hear Sion explain more about the key changes in the GAMP 5 Second Edition in our interview video: ## Learn more about computerized system compliance Don't know your CSV from your CSA? Drowning in IQs, OQs and PQs? Worried what your FDA inspector will expect to see? Download our [complete guide to computerized system compliance in 2022](/resources/complete-guide-computerized-system-compliance) to get yourself up to speed on the GAMP 5 Second Edition and a range of other topics.